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NORVASC®(amlodipine besylate)

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NORVASC® Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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1 INDICATIONS AND USAGE

1.1 Hypertension

NORVASC® is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood...

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2 DOSAGE AND ADMINISTRATION

2.1 Adults

The usual initial antihypertensive oral dose of NORVASC is 5 mg once daily, and the maximum dose is 10 mg once daily.

...

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3 DOSAGE FORMS AND STRENGTHS

Tablets: 2.5 mg white, diamond, flat-faced, beveled edged, with "NORVASC" on one side and "2.5" on the other Tablets: 5 mg white, elongated octagon, flat-faced, beveled edged, engraved with both...

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4 CONTRAINDICATIONS

NORVASC is contraindicated in patients with known sensitivity to amlodipine.

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5 WARNINGS AND PRECAUTIONS

5.1 Hypotension

Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. Because of the gradual onset of...

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6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the...

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7 DRUG INTERACTIONS

7.1 Impact of Other Drugs on Amlodipine

CYP3A Inhibitors

Co-...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

The limited available...

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10 OVERDOSAGE

Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly a reflex tachycardia. In humans, experience with intentional overdosage of NORVASC is limited.

...
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11 DESCRIPTION

NORVASC is the besylate salt of amlodipine, a long-acting calcium channel blocker.

Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow-channel blocker) that inhibits...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Rats and mice treated with amlodipine maleate in the diet for up to two years, at...

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14 CLINICAL STUDIES

14.1 Effects in Hypertension

Adult Patients

The antihypertensive...

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16 HOW SUPPLIED/STORAGE AND HANDLING

2.5 mg Tablets

NORVASC – 2.5 mg Tablets (amlodipine besylate equivalent to 2.5 mg of amlodipine per...

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NORVASC®
(amlodipine besylate)
2.5-mg, 5-mg, and 10-mg tablets

Read this information carefully before you start taking NORVASC (NORE-vask)...

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Resources

NORVASC Savings Card
For questions regarding the NORVASC Savings Card, please call (855) 252-0283
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